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Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final version of the opinion on Phenoxyethanol in cosmetic products
Accepted Manuscript Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final version of the opinion on Phenoxyethanol in cosmetic products Werner Lilienblum PII:
S0273-2300(16)30328-2
DOI:
10.1016/j.yrtph.2016.11.007
Reference:
YRTPH 3720
To appear in:
Regulatory Toxicology and Pharmacology
Received Date: 31 October 2016 Accepted Date: 1 November 2016
Please cite this article as: Scientific Committee on Consumer Safety (SCCS), Lilienblum, W., Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final version of the opinion on Phenoxyethanol in cosmetic products, Regulatory Toxicology and Pharmacology (2016), doi: 10.1016/ j.yrtph.2016.11.007. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
-> requires double line spacing format and line numbering
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Opinion of the Scientific Committee on Consumer safety (SCCS) – Final version of the Opinion on
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Phenoxyethanol in cosmetic products
RI PT
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Phenoxyethanol CAS n. 122-99-6 as preservative is regulated in Annex V/29 of the
7
Cosmetics Regulation (EC) n. 1223/2009.
8
According to the Cosmetics Regulation (EC) n.1223/2009 Phenoxyethanol is authorized
9
as a preservative in cosmetic formulations at a maximum concentration of 1.0%.
SC
6
In September 2012, the Commission received a risk assessment submitted by the French
11
Agency ANSM (Agence nationale de sécurité des médicaments et des produits de santé)
12
which rose concerns about the use of Phenoxyethanol as preservatives in cosmetic
13
products.
14
The ANSM report (Evaluation du risque lié à l'utilisation du phénoxyéthanol dans les
15
produits cosmétiques) concludes that the maximum authorised concentration (currently
16
of 1%) of Phenoxyethanol for use as a preservative should be lowered to 0.4% in
17
cosmetic products for children less than three years. In addition, Phenoxyethanol should
18
not be used in cosmetic products intended for their nappy area. The Commission received
19
information from other member States which raised similar concern on the use of
20
Phenoxyethanol, in particular on children.
21
In December 2013, in response to a call for data on Phenoxyethanol by the Commission,
22
Cosmetics Europe submitted a safety dossier in order to defend the current use of
23
Phenoxyethanol as preservative in cosmetic formulations at a maximum concentration of
24
1.0%.
25
In December 2014, additional information from Cosmetics Europe (Subm. II) was
26
received by the Commission and in July 2015 the submission of data was complemented
27
with a safety assessment tool, such as the physiologically based pharmacokinetic (PBPK)
AC C
EP
TE D
M AN U
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1
ACCEPTED MANUSCRIPT
modelling, in order to provide a perspective on systemic exposure of phenoxyethanol in
2
humans (absorption, distribution, metabolism and excretion).
3
The SCCS considers 2-phenoxyethanol safe for use as a preservative with a maximum
4
concentration of 1.0%, taking into account the information provided.
5
The toxicokinetics default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin
6
of Safety (MoS) of 25 instead of 100 for the safety assessment of 2-phenoxyethanol.
7
Therefore, the MoS of about 50 for children also covers this specific age group who might
8
be higher exposed to 2-phenoxyethanol than adults.
9
This Opinion does not take into account exposure from sources other than cosmetics.
SC
10
12 13
Key words:
M AN U
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RI PT
1
SCCS, scientific opinion, Phenoxyethanol, Regulation 1223/2009, CAS No. 122-99-6, EC No. 204-589-7
14 Reference:
16
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_195.pdf
EP AC C
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TE D
15
2
ACCEPTED MANUSCRIPT
The SCCS considers 2-phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0%
•
The Margin of Safety (MoS) of about 50 for children also covers this specific age group
•
This Opinion does not take into account exposure from sources other than cosmetics.
AC C
EP
TE D
M AN U
SC
Max. 125 characters incl. spaces per highlight
RI PT
•
S0273-2300(16)30328-2
DOI:
10.1016/j.yrtph.2016.11.007
Reference:
YRTPH 3720
To appear in:
Regulatory Toxicology and Pharmacology
Received Date: 31 October 2016 Accepted Date: 1 November 2016
Please cite this article as: Scientific Committee on Consumer Safety (SCCS), Lilienblum, W., Opinion of the Scientific Committee on Consumer Safety (SCCS) – Final version of the opinion on Phenoxyethanol in cosmetic products, Regulatory Toxicology and Pharmacology (2016), doi: 10.1016/ j.yrtph.2016.11.007. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
-> requires double line spacing format and line numbering
1 2
Opinion of the Scientific Committee on Consumer safety (SCCS) – Final version of the Opinion on
4
Phenoxyethanol in cosmetic products
RI PT
3
5
Phenoxyethanol CAS n. 122-99-6 as preservative is regulated in Annex V/29 of the
7
Cosmetics Regulation (EC) n. 1223/2009.
8
According to the Cosmetics Regulation (EC) n.1223/2009 Phenoxyethanol is authorized
9
as a preservative in cosmetic formulations at a maximum concentration of 1.0%.
SC
6
In September 2012, the Commission received a risk assessment submitted by the French
11
Agency ANSM (Agence nationale de sécurité des médicaments et des produits de santé)
12
which rose concerns about the use of Phenoxyethanol as preservatives in cosmetic
13
products.
14
The ANSM report (Evaluation du risque lié à l'utilisation du phénoxyéthanol dans les
15
produits cosmétiques) concludes that the maximum authorised concentration (currently
16
of 1%) of Phenoxyethanol for use as a preservative should be lowered to 0.4% in
17
cosmetic products for children less than three years. In addition, Phenoxyethanol should
18
not be used in cosmetic products intended for their nappy area. The Commission received
19
information from other member States which raised similar concern on the use of
20
Phenoxyethanol, in particular on children.
21
In December 2013, in response to a call for data on Phenoxyethanol by the Commission,
22
Cosmetics Europe submitted a safety dossier in order to defend the current use of
23
Phenoxyethanol as preservative in cosmetic formulations at a maximum concentration of
24
1.0%.
25
In December 2014, additional information from Cosmetics Europe (Subm. II) was
26
received by the Commission and in July 2015 the submission of data was complemented
27
with a safety assessment tool, such as the physiologically based pharmacokinetic (PBPK)
AC C
EP
TE D
M AN U
10
1
ACCEPTED MANUSCRIPT
modelling, in order to provide a perspective on systemic exposure of phenoxyethanol in
2
humans (absorption, distribution, metabolism and excretion).
3
The SCCS considers 2-phenoxyethanol safe for use as a preservative with a maximum
4
concentration of 1.0%, taking into account the information provided.
5
The toxicokinetics default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin
6
of Safety (MoS) of 25 instead of 100 for the safety assessment of 2-phenoxyethanol.
7
Therefore, the MoS of about 50 for children also covers this specific age group who might
8
be higher exposed to 2-phenoxyethanol than adults.
9
This Opinion does not take into account exposure from sources other than cosmetics.
SC
10
12 13
Key words:
M AN U
11
RI PT
1
SCCS, scientific opinion, Phenoxyethanol, Regulation 1223/2009, CAS No. 122-99-6, EC No. 204-589-7
14 Reference:
16
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_195.pdf
EP AC C
17
TE D
15
2
ACCEPTED MANUSCRIPT
The SCCS considers 2-phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0%
•
The Margin of Safety (MoS) of about 50 for children also covers this specific age group
•
This Opinion does not take into account exposure from sources other than cosmetics.
AC C
EP
TE D
M AN U
SC
Max. 125 characters incl. spaces per highlight
RI PT
•